Cookie policy: This site uses cookies (small files stored on your computer) to simplify and improve your experience of this website. Cookies are small text files stored on the device you are using to access this website. For more information please take a look at our terms and conditions. Some parts of the site may not work properly if you choose not to accept cookies.

Join

Subscribe or Register

Existing user? Login

Medication safety

Researchers unable to identify batches of biologic drugs from 85% of Yellow Card reports

Only 15% of biologic drug batches can be identified from Yellow Card adverse drug reaction (ADR) reports, a study published in Drug Safety (23 December 2019) has found.

Researchers analysed 6,108 electronic ADR reports for recombinant biologics submitted to the Medicines and Healthcare products Regulatory Agency’s Yellow Card reporting scheme between 1 January 2009 and 30 September 2017.

They found found that only 15% of these had identifiable batch numbers, and just 38% of reports had an identifiable name. 

As part of the study, UK Drug Safety Research Unit (DSRU) researchers also asked hospital pharmacists how they recorded product details of biologics during prescribing, dispensing and administration in routine practice.

Of the 61 responses received, they found that pharmacists recorded batch numbers during drug administration 58% and 57% of the time in the inpatient and outpatient settings, respectively. Batch numbers were recorded during dispensing 40% and 38% of the time in the respective settings.

The researchers said that batch numbers were most likely to be recorded when the drug is administered owing to the use of peel-off stickers that contain the batch number. Electronic recording was used more often when dispensing drugs, but EU barcode standards do not require batch numbers to be included.

Saad Shakir, director of the DSRU, said batch traceability “means regulatory bodies and pharmaceutical companies can see whether any reported adverse side effects are about a specific batch, or are more widespread,” allowing action to be “taken promptly”.

He added that while wider use of electronic prescribing should improve batch number recording, “it’s vital we educate and inform health professionals so they understand why this seemingly small task is so important”.

 

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2020.20207522

Have your say

For commenting, please login or register as a user and agree to our Community Guidelines. You will be re-directed back to this page where you will have the ability to comment.

Recommended from Pharmaceutical Press

  • Drugs of Abuse

    Drugs of Abuse

    A concise, easy-to-read guide for healthcare professionals who encounter drug abuse.

    £38.00Buy now
  • Pharmaceutical Toxicology

    Pharmaceutical Toxicology

    Explains the methodology and requirements of pre-clinical safety assessments of new medicines. Includes registration requirements and pharmacovigilance.

    £40.00Buy now
  • Drugs and the Liver

    Drugs and the Liver

    Drugs and the Liver assists practitioners in making pragmatic choices for their patients. It enables you to assess liver function and covers the principles of drug use in liver disease.

    £38.00Buy now
  • Clarke's Analysis of Drugs and Poisons

    Clarke's Analysis of Drugs and Poisons

    Clarke's Analysis of Drugs and Poisons is the definitive reference source of analytical data for drugs and poisons.

    £535.00Buy now
  • International Research in Healthcare

    International Research in Healthcare

    Guidance for students or researchers undertaking a multi-centre research project in health services, medicines use and professional practice.

    £38.00Buy now
  • Print
  • Share
  • Comment
  • Save
  • Print Friendly Version of this pagePrint Get a PDF version of this webpagePDF

Newsletter Sign-up

Want to keep up with the latest news, comment and CPD articles in pharmacy and science? Subscribe to our free alerts.